LubriZenzs

LubriZenzs is a non-sterile, water-based personal lubricant for vaginal and/or penile application during intimate sexual activity. It is formulated to moisturize, lubricate, and supplement the body's natural lubrication, and is compatible with natural rubber latex and polyisoprene condoms but not polyurethane condoms.

The subject device differs from the predicate (Wet Organics Personal Lubricant) in formulation—LubriZenzs includes ingredients such as Tremella fuciformis mushroom extract, caprylhydroxamic acid, and xylitol—and has a longer shelf life of 2 years versus 12 months. Both are water-based, non-sterile, over-the-counter lubricants with identical condom compatibility profiles and undergo equivalent testing for pH, osmolality, biocompatibility, microbiology, and antimicrobial effectiveness.

ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2021 (sensitization), ISO 10993-23:2021 (vaginal irritation), ISO 10993-11:2017 (acute systemic toxicity), ASTM D7661-18 (condom compatibility), and USP standards for appearance, pH, viscosity, osmolality, microbial limits, and antimicrobial effectiveness.

The device has the identical intended use as the predicate—providing lubrication during intimate sexual activity. Although the formulations and shelf life differ, these differences do not raise different safety or effectiveness questions because both devices are water-based, non-sterile, over-the-counter lubricants with the same condom compatibility profile. Biocompatibility testing confirms LubriZenzs is non-cytotoxic, non-sensitizing, non-irritating, and not acutely systemically toxic, matching the safety profile of the predicate.